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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of ITP according to American Society of Hematology (ASH) guidelines at least
3 months before enrollment
- Have completed at least 1 prior treatment for ITP
- Two (including day -2) of the 3 platelet counts taken during the screening and
pre-treatment periods must have fulfilled the following:
- less than 30 x 10^9/L for those subjects not receiving any ITP therapy,
- less than 50 x 10^9/L for those subjects receiving any ITP therapy
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Serum creatinine concentration = 2 mg/dL (= 176.8 µmol/L)
- Adequate liver function, as evidenced by a serum bilirubin = 1.5 times the laboratory
normal range
- Hemoglobin greater than 10.0 g/dL
- Written informed consent
Exclusion Criteria:
- Considered a substantial risk for adverse outcomes because of a clinically important
trend (as determined by the investigator) detected in the platelet counts during the
screening period
- Any known history of bone marrow stem cell disorder
- Any active malignancy. If prior history of cancer other than basal cell carcinoma or
cervical carcinoma in situ, no treatment or active disease within 5 years before
randomization
- Documented diagnosis of arterial thrombosis (ie, stroke, transient ischemic attack, or
myocardial infarction) in the previous year; history of venous thrombosis (ie, deep
vein thrombosis, pulmonary embolism) and receiving anticoagulation therapy
- Unstable or uncontrolled disease or condition related to or impacting cardiac function
(e.g., unstable angina, congestive heart failure [New York Heart Association (NYHA)
greater than class II], uncontrolled hypertension [diastolic greater than 100 mmHg] or
cardiac arrhythmia)
- Have 3 or more of the following predisposing factors for thromboembolic events:
diabetes; smoker using oral contraceptives; hypercholesteremia (> 240 mg/dL);
treatment for hypertension
- Known positive test for human immunodeficiency virus (HIV) infection or hepatitis C
virus
- Received any treatment for ITP (except for a constant dose schedule of
corticosteroids) within 4 weeks before the screening visit
- Received intravenous (IV) immunoglobulin (Ig) or WinRho within 2 weeks before the
screening visit
- Received hematopoietic growth factors, including interleukin (IL)-11 (Neumega®) within
4 weeks before the screening visit
- Past or present participation in any study evaluating polyethylene glycol recombinant
human magakaryopoiesis differentiating factor (PEG-rHuMGDF), recombinant human
thrombopoietin (rHuTPO), or related platelet product
- Received any alkylating agents within 8 weeks before the screening visit or
anticipated use during the time of the proposed study
- Received any monoclonal antibody (eg, rituximab) within 16 weeks before the screening
visit or anticipated use during the time of the proposed study
- Less than 4 weeks since receipt of any therapeutic drug or device that is not FDA
approved for any indication before the screening period
- Less than 2 months since major surgery (including laparoscopic splenectomy)
- Pregnant or breast feeding
- Subjects of reproductive potential who are not using adequate contraceptive
precautions, in the judgment of the investigator
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Secondary Outcome(s)
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Change From Baseline in Peak Platelet Count After Each Dose in Part A
[Time Frame: Baseline and after first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)]
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Number of Participants With a Peak Platelet Count = 100 x 10? Cells/L in Part A
[Time Frame: After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)]
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Peak Platelet Count in Part B
[Time Frame: Day 1 to day 78]
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Time to Peak Platelet Count After Each Dose in Part A
[Time Frame: After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)]
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Number of Participants Who Achieved Targeted Therapeutic Platelet Level in Part A
[Time Frame: After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)]
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Percentage of Participants With an Increase in Platelet Count of = 20 x 10? Cells/L Over Baseline in Part B
[Time Frame: Day 1 to day 78]
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Duration Within the Targeted Therapeutic Platelet Range In Part A
[Time Frame: After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)]
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Number of Participants With a Peak Platelet Count of > 450 x 10? Cells/L in Part A
[Time Frame: After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)]
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Time to Peak Platelet Count in Part B
[Time Frame: Day 1 to day 78]
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Change From Baseline in Peak Platelet Count in Part B
[Time Frame: Baseline and day 1 to day 78]
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Percentage of Participants Who Achieved Targeted Therapeutic Platelet Level In Part B
[Time Frame: Day 1 to day 78]
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Percentage of Participants With a Peak Platelet Count of > 500 x 10? Cells/L in Part B
[Time Frame: Day 1 to day 78]
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Percentage of Participants With a Peak Platelet Count of = 100 x 10? Cells/L in Part B
[Time Frame: Day 1 to day 78]
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Duration Within the Targeted Therapeutic Platelet Range in Part B
[Time Frame: Day 1 to day 78]
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Number of Participants With an Increase in Platelet Count of = 20 x 10? Cells/L Over Baseline in Part A
[Time Frame: After first dose (day 1 to day 15 or 22), and after second dose (day 15 or 22 to day 78)]
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Percentage of Participants With a Peak Platelet Count of > 450 x 10? Cells/L in Part B
[Time Frame: Day 1 to day 78]
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Peak Platelet Count After Each Dose in Part A
[Time Frame: After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)]
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